Pelvic organ prolapse is a common medical condition, affecting almost half of women over the age of 50. (See, Subak et al., “Cost Of Pelvic Organ Prolapse Surgery In The United States”, Obstet Gynecol. 2001; 98(4):646-651.) As the population in the United States ages, there will be an increasing number of women who require treatment for this condition. This medical condition results in lifestyle restriction, social limitations, sexual dysfunction, and pain, but can also lead to more critical conditions such as urinary retention, urinary tract infection, and sepsis.
For over a century, gynecologists have devised reconstructive pelvic surgeries to address this problem. The gold standard for the repair of severe prolapse (vaginal vault prolapse) is the sacrocolpopexy. (See, Ganatra et al., “The Current Status Of Laparoscopic Sacrocolpopexy: A Review”, Eur Urol. 2009. See, also, U.S. Pat. No. 6,592,515.) This procedure suspends the apex of the vagina by affixing a Y-shaped piece of synthetic mesh to the anterior and posterior vaginal walls and suspending this from a strong ligament on the anterior part of the sacrum. This procedure is typically performed via a laparoscopic approach, entering the abdominal cavity to access the sacrum and vaginal tissues, both of which are retroperitoneal (behind the lining of the abdominal cavity). In some subjects (obese patients and individuals with severe abdominal adhesions from multiple prior surgeries), the laparoscopic approach is not possible, and a larger abdominal incision is required.
Vaginal surgery is another common route of repair for pelvic organ prolapse, but the sacrocolpopexy has not been performed via a vaginal incision due to technical constraints. Other surgical repairs performed vaginally have lower success rates. (See, Maher et al., “Surgical Management Of Pelvic Organ Prolapse In Women: A Short Version Cochrane Review”, Neurourol Urodyn. 2008, 27(1):3-12.)
Therefore, there is a need for a surgical device and method which permit the performance of a sacrocolpopexy by accessing the sacrum and vaginal tissues via the vaginal orifice, thus avoiding the abdominal cavity completely.